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Validation Online; is part of the AKC group which has over fifty years experience of QA & QC Implementation tasks and ten years of direct internet documentation sales.

Network Validation Plan. $115.0010001111The Network Validation Master Plan, is the starting point for validation, and hence the most important validation document. It improves validation efficiency greatly by forcing all concerned to document, review, and discuss, the proposed methods and allotted responsibilities. It is an

expected document with the FDA, and a mandated document with the
EU. While in the past network validation was more focused on functions of single user network systems, recently the focus has progressed into network infrastructure, networked systems and on security, authenticity and integrity of data acquired and evaluated by network systems.

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Network User Requirements Specification. $115.0010001112

The document that sets the standard, and specifies your Network requirements in a manner that ensures when a system or piece of network is selected, it will deliver the functions you want, it will have maintenance standards, it will have calibration records, it will have all the documents and records to enable successful validation to be completed. This document was designed to be used as a live document up until the DQ is completed and approved. It uses three levels of URS, URS Level 1, 2 and 3, and is the only URS to guarantee traceability from the URS through to the final PQ and OQ functionality testing. This traceability is a mandatory requirement for Full Life Cycle Validation of Network systems that are the subject of predicate rules. It can be used on mechanical, electrical and software controlled, monitored or driven systems.

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= 27

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Network Design Qualification. $115.0010001113

The Standard Operating Procedure attached to this generic network design qualification protocol, will chapter by chapter, take you through the task of raising a fully detailed document. The main body is split into fourteen tables, each one probing the design requirements and standards for the individual requirement. Safety and security along with user operability are very detailed. The document will lead you through all these design aspects allowing you to delete some you feel are not important to your equipment. It is an easy document to use and will ensure that you’re DQ’s are relevant, up to date and easy to execute. Practically all the requirements are in table form. Allowing fast and clearly presented results to be obtained.

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Network Validation Risk Assessment. $125.0010001114The Risk and Part 11 Validation Risk Assessment (VRA) protocol is becoming the most important document in the validation train. The VRA reassures the regulators that you have looked at specific network functionality and considered the appropriate level of validation that is required. You have also considered various aspects of its use and the implications of any malfunctions. From the results of this exercise the scope of all validation activity can and must be justified. This is a robust and simple to execute document, one that will lead you through the process and

deliver a result that can be used as the foundation for your validation activities.
This VRA now includes the assessment table for categorising and documenting the new 21 CFR Part 11 guidance ruling on what predicate data must be stored in a Part compliant system, along with the new broadsheet to establish your new database of part 11 records. (now mandatory).

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Package Network Validation. (Issue 6) $680.0010001115

The complete chain of regulatory required documentation for the validation of an IT Network system. This Validation Package does not contain the VMP as network qualification will usually be included in the the master VMP or a VMP dedicated to computer controlled equipment and or systems. This package contains one of each of these documents:

VP, URS, DQ, VRA, IQ, OQ, PQ.
Quantity

Network Installation Qualification. $115.0010001115

Installation Qualification (IQ) is an important step in the overall validation and qualification process for software and networked systems. Our protocol leads you through the detailed requirements. GAMP 4, is used as a general guide, however there are some areas where it is better to stick with the FDA interpretations. Validation Online has extensive validation experience, where we know that there is a regulatory sensitive area we make absolutely certain that our documentation is clear, concise and supplies the information the regulators are anticipating. These protocols have evolved over 15 years use in the pharmaceutical and allied industries.

The Network Performance Qualification is the culmination of the validation process. The protocol is used in conjunction with the system operating SOP, to verify that the system process is consistent and correct. The results of the testing must be recorder and reviewed with a view to ensuring that the deviancies (within permitted tolerances) that exist are random and not a trend that will lead to out of specification operation during production use.